Originally created 05/24/00

Government proposes fines for research violations



WASHINGTON (AP) - Federal health officials are proposing fines of up to $250,000 for scientists who violate medical research rules - and fines of $1 million for rule-breaking universities or hospitals - amid criticism that the government hasn't done enough to protect thousands of patients involved in clinical trials.

"This is a clear message that we intend to get serious," Health and Human Services Secretary Donna Shalala said Tuesday, stressing that the government will hold responsible not just the scientist at fault but the entire research institution.

Scientists' wallets will be safe for a while - Shalala still must ask Congress to pass legislation allowing the Food and Drug Administration to fine researchers who break the rules.

But Shalala announced additional steps Tuesday that will start immediately: better training of the local medical boards primarily responsible for overseeing patient safety, tougher requirements that patients be fully informed of research risks, and improved monitoring of how patients fare day-to-day.

FDA investigators have recently uncovered serious violations of basic research rules at some of the nation's most prestigious universities, including the University of Pennsylvania gene therapy experiment that killed an Arizona teen-ager last fall.

To check for further problems, the FDA revealed Tuesday that it had begun unprecedented in-depth inspections of 70 gene therapy experiments around the country.

But the issue isn't just about gene therapy, it's about all medical experiments. HHS' inspector general has repeatedly warned since 1998 that there is little independent monitoring of how patients fare day-to-day in clinical trials, meaning early warning signs that an experiment might be too dangerous are missed. The local medical boards, called "institutional review boards" or IRBs, primarily responsible are overworked and undertrained, the inspector general said.

Several scientists caught violating research rules have claimed they were confused about government requirements.

But the nation's top regulators signaled impatience with that claim.

"I don't accept the confusion defense," Shalala said bluntly.

"These rules have been long-standing," added FDA Commissioner Jane Henney. "They are pretty fundamental."

In fact, some critics have long questioned why the government hasn't better enforced the rules already. Many of the steps Shalala announced Tuesday were recommended by her own inspector general in 1998, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen.

But Shalala said the biggest change is that the government will hold accountable not just scientists who violate the rules, but entire research institutions and IRBs.

President Clinton called the steps vital to ensure not just patient safety but public confidence in the integrity of cutting-edge science.

"We are on the brink of discoveries that are astonishing," Clinton said. "But as committed as we are to further progress, we must be as committed to ensuring ... the safety of those making these new discoveries possible. These new actions are a critical first step."

Today, the FDA's main weapon for safety violations is shutting down the worrisome experiment. That's important when an experiment imminently threatens participants. But often the patient risk isn't that immediate, so the FDA is reluctant to take a step that Henney called draconian. The FDA hopes fines will make more scientists behave.

Although the FDA already fines certain medical companies for various violations, Congress would have to approve this new type of fine. It's not clear that lawmakers would have time to pass such a bill this year, or that the Republican-led Congress, long unfriendly to the FDA, would even approve. Sen. Bill Frist, R-Tenn., a physician who has led Congress' investigation of patient safety in clinical trials, did not comment Tuesday.

Among other steps the agency is taking immediately:

-Scientists must prove how well participants were informed of an experiment's risks, including telling them about unexpected risks that arise after a study begins.

-IRBs and any clinical investigator who receives federal funding must get special training in patient safety and bioethics.

-Early-stage clinical trials will undergo more of the intensive patient monitoring now mostly reserved for end-stage, or Phase III, experiments.

-Scientists must disclose to study participants any financial interest in the treatment they're testing.